Benalmadena

Researchers are evaluating AZD0292, a bispecific IgG1k monoclonal antibody, for preventing exacerbations in bronchiectasis patients who are chronically colonized with Pseudomonas aeruginosa PsA. This Phase IIb study compares two dosage regimens of AZD0292 administered intravenously with placebo in participants aged 12 years and older. The study mainly focuses on non-cystic fibrosis bronchiectasis patients with frequent pulmonary exacerbations due to chronic PsA colonization, which negatively affects lung function, quality of life, and survival. Additionally, patients with cystic fibrosis bronchiectasis colonized with PsA are included as an exploratory group. Participants will receive either high-dose or low-dose AZD0292 starting on Day 1 via IV infusion, or placebo administered similarly. Subsequent doses will follow a schedule of assessments. This randomized, double-blind, placebo-controlled, parallel study aims to assess the efficacy, safety, and pharmacokinetics of AZD0292 over a variable follow-up period ranging from a minimum of 28 weeks up to 52 weeks. The trial also includes monitoring for adverse events and immune responses to the treatment. During the study, participants will undergo evaluations including lung function tests, quality of life questionnaires, and monitoring of exacerbation rates. Blood samples will be collected to measure drug concentration and antibody development. Safety assessments will continue through the treatment period and for up to 24 weeks after the last dose. The primary outcome is the annualized rate of exacerbations over the follow-up time, and secondary measures include severe exacerbation rates, time to first exacerbation, and changes in quality of life scores. Total participation spans from screening through the treatment and follow-up phases.

Researchers are evaluating the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.

Researchers are evaluating ibuzatrelvir, an oral medication, to determine its effectiveness and safety in adults and adolescents aged 12 years and older with COVID-19 who are not hospitalized but are at high risk for severe illness. The study is a phase 3, randomized, double-blind trial comparing ibuzatrelvir with a placebo. Participants must have confirmed SARS-CoV-2 infection with symptoms starting within 5 days and meet specific risk factor criteria based on age. Eligible participants will be randomly assigned to receive either ibuzatrelvir or a matching placebo twice daily by mouth for 5 days. The study allows co-administration of standard care treatments available locally. The total study duration is about 6 months, including follow-up. Participants will be monitored for emergency department visits related to COVID-19, hospitalizations, and mortality up to 28 days after starting treatment. Additional evaluations include symptom resolution, occurrence of long COVID symptoms, viral RNA levels, and safety measures such as adverse events through 24 weeks. The study involves regular assessments, including clinical visits and laboratory tests, to track outcomes and safety over time.

Asthma is a long-term condition where the airways become narrow and swollen due to inflammation, causing symptoms that can vary and worsen unexpectedly. This trial is evaluating depemokimab, a monoclonal antibody, to see how it impacts lung structure and function in adults with type 2 inflammatory asthma, particularly those with an eosinophilic phenotype. The study is a Phase 3b treatment trial sponsored by GlaxoSmithKline. Participants with asthma characterized by type 2 inflammation will receive depemokimab. The study uses advanced imaging and bronchoscopy to assess changes in lung features. Treatment involves administering depemokimab, with evaluations performed up to 52 weeks. Participants who consent to a biopsy sub-study will undergo additional bronchoscopy procedures under specific safety criteria. During the study, participants will undergo lung imaging, bronchoscopy, and tests measuring mucus plug volume, airway wall thickness, and lung function at several time points including weeks 26 and 52. Researchers will monitor side effects and serious adverse events up to 65 weeks. The total study duration allows detailed assessment of depemokimabs effects on lung health and participant safety.

This research aims to evaluate whether taking the Ovosicare4 Fertility food supplement helps increase the chance of becoming pregnant in women aged 32 to 38 years who have been trying to conceive for at least six months before starting supplementation. The study is observational and focuses on real-world use of this supplement containing a combination of MYODCI, antioxidants, vitamins, and minerals. Participants will follow a supplementation plan prescribed as part of standard clinical practice. The study does not require additional tests or extraordinary visits beyond those normally done in routine care. The observation period for each participant will last up to 18 months, but it may end sooner if pregnancy occurs. During the study, there will be a total of three visits. Women in the study will undergo routine assessments including blood tests for biochemical and hormonal panels, karyotype analysis, and ultrasound exams to monitor anatomy and follicle count. Researchers will track spontaneous pregnancy rates, time until pregnancy, safety, tolerability, satisfaction, and adherence to supplementation. Live birth rates will also be recorded after pregnancy confirmation. The study provides follow-up through 9 months after enrollment or until pregnancy.